Support AP 1.0 and Devices 1.0

Pinnacle 21 General General Discussion
1

Hi Joyce,

Unfortunately there are no plans for support of AP or Medical Device CDISC standards in the upcoming release of OpenCDISC v2.0.

So far CDRH does not require any specific format for submission data.

Kind Regards,

Sergiy

2

Dear OpenCDISC: Are there any plans to support Associated Persons (which is part of 3,2) and Devices? Thanks, Joyce